MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL EXPRESSEW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288233
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo revealed that the device's upper and lower jaw has detached from the shaft.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the expressew iii ac+ gun would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life.As per ifu; visually inspect the instrument and check for damage and wear.Jaws and teeth should align properly.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during a surgical procedure, after the assembly of the inputs (plate and needle) it was found that the clamp was in good condition.However, when passing the first point in the tissue, the clamp was completely disassembled in its jaws.Attempts were made to verify whether it had a solution, without it being possible.The surgery was performed successfully with the use of other tweezers that covered the need.

• Brand Name: EXPRESSEW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25337489
• Report Number: 1221934-2026-02334
• Device Sequence Number: 5368477
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: (01)10886705027101(10)6223092604
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 288233
• Device Lot Number: 6223092604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 06/15/2026; 06/18/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/16/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown